Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis

Recruiting now · Phase 1

Conditions studied: Systemic Sclerosis

In brief

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Systemic Sclerosis

Key facts

Study ID

NCT05016804

Run by

The Foundation for Orthopaedics and Regenerative Medicine

People needed

20

Starts

2022-07-04

Expected to finish

2026-11-01

Last updated by the study team

2025-04-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Systemic Sclerosis
• Understanding and willingness to sign a written informed consent document

You may not qualify if…

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant
• Hypersensitivity to sulfur

Where it is running

• Medical Surgical Associates Center — St John's, Antigua and Barbuda (enrolling)
• Center for Investigation in Tissue Engineering and Cellular Therapy — Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

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